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Back to the forum  Query: 2017-11-22 17:32 CET (UTC+1h)
 
Ramesh Ramalingam
Junior

India,
2017-09-05 07:35

Posting: # 17776
Views: 935
 

 subject inclusion criteria in PK and stat and BE conclusion [Regulatives / Guidelines]

Dear All,

I have more doubt on subject inclusion criteria for pharmacokinetic and statistical analysis in fully replicate (Including NTI drugs) and partial replicate design BE studies. could you please suggest the subject inclusion criteria for PK and stat analysis (including who's data can be considered for BE)? Also, How many treatment periods subject should be completed in the study?



Regards,
Ramesh Ramalingam
ElMaestro
Hero

Denmark,
2017-09-05 08:26

@ Ramesh Ramalingam
Posting: # 17777
Views: 812
 

 subject inclusion criteria in PK and stat and BE conclusion

Hi Ramesh,

Statistics:
EU: Include those who provide both a Test and Reference period.
US: Include those who provide data.

Descriptive PK: Done on all data as much as possible.

I have a feeling you may have asked about something else, though?

I could be wrong, but…


Best regards,
ElMaestro

No, I still don't believe much in the usefulness of IVIVCs for OIPs when it comes to picking candidate formulations for the next trial. This is not the same as saying I don't believe in IVIVCs.
Ramesh Ramalingam
Junior

India,
2017-09-05 09:17
(edited by Ohlbe on 2017-09-05 09:59)

@ ElMaestro
Posting: # 17778
Views: 814
 

 subject inclusion criteria in PK and stat and BE conclusion

Dear ElMaestro,

Thank you very much for your response.

Based on your response i understand that the subject inclusion criteria for pharmacokinetic and statistical analysis as follows for NTI drugs:

SWR calculations & SWT calculations & Average BE: subject should completed all the study periods
SWR calculations & Average BE:subject who completed with Reference twice and Test once
SWT calculations & Average BE:subject who completed with Reference once and Test twice
SWR calculations:subject who completed with Reference twice
SWT calculations:subject who completed with Test twice

Based on this subject should complete at least two treatment periods of the study wright?

for HVDs(fully replicate design):

SWR calculations & Average BE: subject who completed all the study periods
SWR calculations:subject who completed with Reference twice
Average BE:Subject who complete at least one test and one reference treatment

Hence, Subject should complete at least one test and one reference treatment period or both reference treatment periods of the study, wright?

Kindly advice if anything wrong.

Regards,
Ramesh Ramalingam


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]
ElMaestro
Hero

Denmark,
2017-09-05 09:20

@ Ramesh Ramalingam
Posting: # 17779
Views: 798
 

 subject inclusion criteria in PK and stat and BE conclusion

Hi Ramesh,

please be specific: are you targeting US or EU or some other territory?

I could be wrong, but…


Best regards,
ElMaestro

No, I still don't believe much in the usefulness of IVIVCs for OIPs when it comes to picking candidate formulations for the next trial. This is not the same as saying I don't believe in IVIVCs.
Ramesh Ramalingam
Junior

India,
2017-09-05 09:22

@ ElMaestro
Posting: # 17780
Views: 796
 

 subject inclusion criteria in PK and stat and BE conclusion

» Hi Ramesh,
»
» please be specific: are you targeting US or EU or some other territory?

US
ElMaestro
Hero

Denmark,
2017-09-05 10:16

@ Ramesh Ramalingam
Posting: # 17781
Views: 806
 

 subject inclusion criteria in PK and stat and BE conclusion

Hi Ramesh,

» US

Then all variance components come from a mixed model that has been fit using REML. Any subject who has an R or T value or any quantity of both contributes (let's leave 'outliers' and aberrant values out for the purpose of this discussion).

I could be wrong, but…


Best regards,
ElMaestro

No, I still don't believe much in the usefulness of IVIVCs for OIPs when it comes to picking candidate formulations for the next trial. This is not the same as saying I don't believe in IVIVCs.
yicaoting
Regular

NanKing, China,
2017-09-05 15:23

@ Ramesh Ramalingam
Posting: # 17782
Views: 763
 

 At least twice R or twice T for sWR and sWT

» SWR calculations:subject who completed with Reference twice
» SWT calculations:subject who completed with Test twice

For NTID, if you apply the formula to calc sWR or sWT, you MUST have at least twice R or twice T.
Those subjects with only one R, will have no contribution in calculating sWR. Similar to that of sWT.
This is just for sWR and sWT, and sWR/sWT and it's %CI.
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